Efficacy, pharmacokinetics, and safety of icatibant for the treatment of Japanese patients with an acute attack of hereditary angioedema: A phase 3 open-label study

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  • Hide Michihiro
    Department of Dermatology, Institute of Biomedical & Health Sciences, Hiroshima University
  • Fukunaga Atsushi
    Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine
  • Maehara Junichi
    Emergency and General Medicine Center, Saiseikai Kumamoto Hospital
  • Eto Kazunori
    Gastroenterology, Tomakomai City Hospital
  • Hao James
    Shire, a Takeda Company
  • Vardi Moshe
    Shire, a Takeda Company
  • Nomoto Yuji
    Department of Palliative Care Internal Medicine, Niigata City General Hospital

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<p>Background: Hereditary angioedema (HAE) is a genetic disease characterized by recurrent swelling episodes affecting the skin, gastrointestinal mucosa, and upper respiratory tract.</p><p>Methods: A phase 3, single-arm, open-label study was performed to evaluate a selective bradykinin B2 receptor antagonist, icatibant, for the treatment of acute attacks in Japanese patients with HAE Type I or II. After the onset of an acute attack, icatibant 30 mg was administered by the patient or a healthcare professional via subcutaneous injection in the abdomen.</p><p>Results: Eight patients who had an attack affecting the skin (n = 4), abdomen (n = 3), or larynx (n = 1) were treated with icatibant (3 of the injections were self-administered). The median time to onset of symptom relief was 1.75 h (95% confidence interval, 1.00-2.50), and all patients had symptom relief within 5 h after administration. The time to maximum plasma concentration of icatibant was 1.79 h, and the maximum plasma concentration was 405 ng/ml. Seven patients experienced an injection site reaction, and 3 patients had adverse events (2 patients had a worsening or repeat HAE attack 29.0 and 18.3 h after icatibant administration, respectively, and 1 had headache).</p><p>Conclusions: Although the number of patients is small, the efficacy and tolerability of icatibant for acute attacks were demonstrated in Japanese patients with HAE, regardless of self-administration or administration by healthcare professional.</p>

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